Study of Growing Biofilm by an Antiplaque Mouthrinse (Bain de bouche)

Tracking Information
First Submitted Date ICMJE	February 5, 2009
First Posted Date ICMJE	February 6, 2009
Last Update Posted Date	September 23, 2009
Study Start Date ICMJE	February 2009
Actual Primary Completion Date	March 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 5, 2009)	Plaque index of Quickley-Hein modified by Tureski. Plaque deposits are scored on all natural teeth (except third molars) after staining. [ Time Frame: Measures are done on days 5 of the two plaque growth periods ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00838266 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 5, 2009)	Product tolerance [ Time Frame: on days 5 of the two plaque growth periods ]; Product acceptability (oral sensation) [ Time Frame: on days 5 of the two plaque growth periods ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study of Growing Biofilm by an Antiplaque Mouthrinse
Official Title ICMJE	A Double Blind Randomized, Placebo-controlled, Cross-over Trial to Evaluate the Efficiency of a Mouthrinse, Containing Red Grape Seed Extract and nicométhanol Fluorhydrate, in the Control of Dental Plaque Deposit in a 4-days Plaque Regrowth Model
Brief Summary	The objective of this study is to evaluate the efficiency of a new mouthrinse on dental plaque deposits. The study is carried out on 50 volunteers that are asked to use the mouthrinse without any other oral hygiene measure, during 4 days. It is a double bind, cross-over, randomized design: the same subjects test the active product and the placebo.
Detailed Description	The prevention of oral diseases is mainly targeted at the control of dental plaque. While tooth brushing is an effective method to remove plaque mechanically, it is not always sufficient and chemical antiplaque agents could be helpful. Some of them are used for their antibacterial action, the gold standard being chlorhexidine. Despite the great benefit of this bactericidal approach, the search continues for active ingredients that could prevent dental plaque formation without affecting the biological equilibrium within the oral cavity. The aim of this study is to evaluate the efficiency of a mouthrinse, containing red grape seed extract and nicométhanol fluorhydrate, in the control of dental plaque deposit in a 4-days plaque regrowth model. The study is a double blind randomized cross-over design, involving 50 healthy volunteers. During the treatment periods (4 days) no oral hygiene, measures excepting rinsing with the allocated product (active/non active) are permitted. On day 1, the subjects receive professional prophylaxis. The mouthrinse is used pure, three times per day, after each meal. On day 5, subjects will be scored for disclosed plaque using the Quigley Hein index (modified by Turesky). After a 2 weeks wash-out period, the subject receives the other product (active/non active) and uses it as in the first period. On day 5, subjects will be scored again for disclosed plaque
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Dental Plaque
Intervention ICMJE	Drug: mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate) Antiplaque mouthrinse containing active component three times a day, during 1 minute, for 4 days; Other: mouthrinse containing non-active component Antiplaque mouthrinse containing non-active component three times a day, during 1 minute, for 4 days
Study Arms	Experimental: 1 Antiplaque mouthrinse containing active component (Grape Seed Extract + nicométhanol fluorhydrate) Intervention: Drug: mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate); Placebo Comparator: 2 Antiplaque mouthrinse containing non-active component Intervention: Other: mouthrinse containing non-active component
Publications *	Addy M. Evaluation of clinical trials of agents and procedures to prevent caries and periodontal disease: choosing products and recommending procedures. Int Dent J. 1995 Jun;45(3):185-96. Review.; Guidelines for acceptance of chemotherapeutic products for the control of supragingival dental plaque and gingivitis. Council on Dental Therapeutics. J Am Dent Assoc. 1986 Apr;112(4):529-32.; Yates RJ, Shearer BH, Morgan R, Addy M. A modification to the experimental gingivitis protocol to compare the antiplaque properties of two toothpastes. J Clin Periodontol. 2003 Feb;30(2):119-24.; Furiga A, Lonvaud-Funel A, Dorignac G, Badet C. In vitro anti-bacterial and anti-adherence effects of natural polyphenolic compounds on oral bacteria. J Appl Microbiol. 2008 Nov;105(5):1470-6. doi: 10.1111/j.1365-2672.2008.03882.x. Epub 2008 Sep 13.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 5, 2009)	50
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	March 2009
Actual Primary Completion Date	March 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Healthy volunteer; without caries; with at least 20 natural teeth excluding third molars; Women using contraceptives for at least twelve weeks and while on study; Protected by French social security system; Written informed consent Exclusion Criteria: Pregnancy or breast feeding; Volunteers with partial denture or orthodontic appliance; Person protected by the law who; Person unable to give their consent to participate to the study.; Under aged; Current participation in another clinical trial; Oral pathologies; Systemic diseases; Volunteers allergic to of the componentst of the tested products; Volunteers with hyposalivation or xerostomia; Treatment with antibiotics o intestinal antiseptics within 3 month before inclusion; Treatment with oral antiseptics within 1 month before inclusion; Alcoholic consumption more than 20 g/day (or 2 glasses); Heavy smokers; Volunteers drinking a lot of tea or coffee
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00838266
Other Study ID Numbers ICMJE	CHUBX 2008/05
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
Study Sponsor ICMJE	University Hospital, Bordeaux
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Cécile BADET, MD University Hospital, Bordeaux
PRS Account	University Hospital, Bordeaux
Verification Date	September 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP